Regulating Emotions Like An eXpert Among Adolescents With ADHD
Part of paid clinical trials in Blacksburg, Virginia.
- Sponsor
- Virginia Polytechnic Institute and State University
- Study ID
- NCT06725186
- Status
- Recruiting
Conditions
- EMI Smartphone App Pilot
- Psychoeducational Waitlist Control
- RELAX Telehealth Intervention
Eligibility Criteria
- Sex
- ALL
- Age
- 11 Years - 16 Years
- Healthy Volunteers
- Not accepted
Interventions
- RELAX — BEHAVIORALThe RELAX intervention is a social-emotional intervention consisting of 8 weekly, 1.5 hr sessions and a booster session 1 month and 6 months after the completion of RELAX. During the first 60 minutes of RELAX sessions, parents and adolescents meet separately; during the last 30 minutes combined parent-adolescent discussion and problem-solving activities take place. RELAX is structured such that parents learn emotion regulation/coping skills the week prior to them being taught to the adolescents. Group sessions will involve both didactics and discussion of topics including psychoeducation, basic cognitive/behavioral principles, emotional awareness, emotion regulation strategies, parent emotion socialization practices, coping skills, conflict management strategies, and communication skills.
- Psychoeducational Materials — BEHAVIORALInfographics with information on emotion regulation development, emotion regulation strategies, and strategies for managing interpersonal conflict, including when different strategies are more or less effective will be provided to participants via email.
Study Details
This study consists of a randomized controlled trial assessing the acceptability, feasibility, and efficacy of the RELAX (Regulating Emotions Like An eXpert) Intervention. Following randomization, 30 families will receive the RELAX intervention and 30 families will receive psychoeducational materials as part of a control condition. Additionally, 10 families from the RELAX condition will participate in a pilot study and focus groups to give feedback on developed smartphone apps to support skill use during and following completion of RELAX.
Key Dates
- Start date
- Jan 15, 2025
- Status verified
- Jan 2026
- Primary completion
- May 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: RELAX Interventiongroup-based RELAX telehealth intervention
- Active Comparator: Psychoeducational Waitlist ControlThe psychoeducational component will consist of infographics regarding emotion regulation strategies and managing interpersonal conflict.
Primary Outcome Measure
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) [ Time Frame: From enrollment to the 6-month follow-up period. ]
Central Contacts
- Rosanna Breaux, PhD5402318276
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Child Study Center | Blacksburg | Virginia | 24060 |
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